- Approval Id
- 051665979ca8e55c
- Drug Approval Emc Name
- Crystacide 1% w/w Cream 40g
- Drug Name
- Crystacide 1% w/w Cream 40g
- Company Name
- Reig Jofre UK Ltd
- Company Address
- Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE, UK
- Company Website
- //www.reigjofre.com/en
- Company Telephone
- 01803 300401
- Company Medical Info Direct Line
- 0330 1359 434
- Company Medical Info Email
- MedInfoUK@reigjofre.com
- Company Customer Care Direct Line
- 01803 300401
- Atc Code
- D08A
- Legal Category
- Pharmacy
- Authorisation Holder
- Reig Jofre UK Limited
Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE,
United Kingdom
- Authorisation Number
- PL 44095/0011
- Authorisation Date
- 17/01/2006
- Instruction Authorisation Holder
- Reig Jofre UK Limited
Follaton House, Plymouth Road, Totnes, Devon, TQ9 5NE,
United Kingdom
- Instruction Authorisation Number
- PL 44095/0011
- Instruction Authorisation Date
- 17/01/2006
- Instruction Composition
- \*\*Active ingredient\*\*
Hydrogen peroxide 1.0% (w/w)
1g of cream contains 10mg of hydrogen peroxide at a concentration of 1%.
- Instruction Dosage Form
- Cream.
- Instruction Clinical Particulars
- 4.1 Therapeutic indications
Crystacide cream is intended for topical application for the treatment of primary and secondary superficial skin infections caused by organisms sensitive to hydrogen peroxide.4.2 Posology and method of administration
\*Adults, elderly and children\*
Crystacide cream is applied 2-3 times daily on the infected skin area. The treatment period should not exceed 3 weeks. A dry film will appear on the skin after application, this can be washed off with water.4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.4.4 Special warnings and precautions for use
Contact with the eyes should be avoided. Crystacide Cream should not be used on large or deep wounds and should not be applied to healthy skin. Hydrogen peroxide can bleach fabric\*\*\*.\*\*\*
Salicylic acid is a mild irritant and can cause dermatitis.
Crystacide Cream also contains propylene glycol which may cause skin irritation.4.5 Interaction with other medicinal products and other forms of interaction
Crystacide cream is incompatible with iodine, permanganates and other stronger oxidising agents.4.6 Pregnancy and lactation
To be used under medical guidance.4.7 Effects on ability to drive and use machines
Not applicable.4.8 Undesirable effects
A mild sensation of burning may be experienced for a short time after application.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.4.9 Overdose
Not applicable
- Instruction Pharmacology
- 5.1 Pharmacodynamic properties
\*\*ATC Code: D0 8A\*\*
\*\*Antiseptics and Disinfectants\*\*
Hydrogen peroxide is a well-known antiseptic agent, and is effective against a majority of pathogenic micro-organisms.
In-vitro pharmacology studies have shown that hydrogen peroxide has both activity against a wide variety of micro-organisms, and is a potent antibacterial agent with effect against Gram-positive as well as Gram-negative bacteria.
In-vitro studies have shown that the bactericidal activity of Crystacide cream 1% is equal in effect compared with a 1% aqueous solution of hydrogen peroxide, and the duration of action is longer for the cream.
There are no known pathogenic bacteria or fungi that develop resistance to hydrogen peroxide.5.2 Pharmacokinetic properties
Reports on the rate of absorption, distribution and excretion of hydrogen peroxide after oral administration are sparse. In the absence of stabilising agent, hydrogen peroxide gradually decomposes to oxygen and water. The decomposition is rapid in the presence of the endogenous enzyme catalase or peroxidase.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
- Instruction Pharmaceutical Particulars
- 6.1 List of excipients
Glyceryl monolaurate
Glyceryl monomyristate
Macrogolstearate 5000
Propylene glycol
Citric acid anhydrous
Sodium hydroxide
Sulphuric acid, 1M
Sodium oxalate
Salicylic acid
Disodium edetate
Sodium pyrophosphate
Sodium stannate
Purified water6.2 Incompatibilities
Iodine, permanganates and other stronger oxidising agents.6.3 Shelf life
Unopened: 2 years
After first opening the container: 28 days6.4 Special precautions for storage
Store below 25ºC, in a dry place.6.5 Nature and contents of container
Crystacide cream is filled into polyethylene tubes pigmented with titanium dioxide, and fitted with polypropylene caps. Each tube is subsequently packed in a unit, printed boxboard carton, in pack sizes of 5g, 10g, 25g and 40g.6.6 Special precautions for disposal and other handling
Not applicable
- Instruction Content
- ## Composition
\*\*Active ingredient\*\*
Hydrogen peroxide 1.0% (w/w)
1g of cream contains 10mg of hydrogen peroxide at a concentration of 1%.
## Pharmaceutical Form
Cream.
## Clinical Particulars
4.1 Therapeutic indications
Crystacide cream is intended for topical application for the treatment of primary and secondary superficial skin infections caused by organisms sensitive to hydrogen peroxide.4.2 Posology and method of administration
\*Adults, elderly and children\*
Crystacide cream is applied 2-3 times daily on the infected skin area. The treatment period should not exceed 3 weeks. A dry film will appear on the skin after application, this can be washed off with water.4.3 Contraindications
Hypersensitivity to the active substance or any of the excipients.4.4 Special warnings and precautions for use
Contact with the eyes should be avoided. Crystacide Cream should not be used on large or deep wounds and should not be applied to healthy skin. Hydrogen peroxide can bleach fabric\*\*\*.\*\*\*
Salicylic acid is a mild irritant and can cause dermatitis.
Crystacide Cream also contains propylene glycol which may cause skin irritation.4.5 Interaction with other medicinal products and other forms of interaction
Crystacide cream is incompatible with iodine, permanganates and other stronger oxidising agents.4.6 Pregnancy and lactation
To be used under medical guidance.4.7 Effects on ability to drive and use machines
Not applicable.4.8 Undesirable effects
A mild sensation of burning may be experienced for a short time after application.
Reporting of side effects
If you get any side effects talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.4.9 Overdose
Not applicable
## Pharmacological Properties
5.1 Pharmacodynamic properties
\*\*ATC Code: D0 8A\*\*
\*\*Antiseptics and Disinfectants\*\*
Hydrogen peroxide is a well-known antiseptic agent, and is effective against a majority of pathogenic micro-organisms.
In-vitro pharmacology studies have shown that hydrogen peroxide has both activity against a wide variety of micro-organisms, and is a potent antibacterial agent with effect against Gram-positive as well as Gram-negative bacteria.
In-vitro studies have shown that the bactericidal activity of Crystacide cream 1% is equal in effect compared with a 1% aqueous solution of hydrogen peroxide, and the duration of action is longer for the cream.
There are no known pathogenic bacteria or fungi that develop resistance to hydrogen peroxide.5.2 Pharmacokinetic properties
Reports on the rate of absorption, distribution and excretion of hydrogen peroxide after oral administration are sparse. In the absence of stabilising agent, hydrogen peroxide gradually decomposes to oxygen and water. The decomposition is rapid in the presence of the endogenous enzyme catalase or peroxidase.5.3 Preclinical safety data
There are no pre-clinical data of relevance to the prescriber which are additional to that already included in other sections of the SPC.
## Pharmaceutical Particulars
6.1 List of excipients
Glyceryl monolaurate
Glyceryl monomyristate
Macrogolstearate 5000
Propylene glycol
Citric acid anhydrous
Sodium hydroxide
Sulphuric acid, 1M
Sodium oxalate
Salicylic acid
Disodium edetate
Sodium pyrophosphate
Sodium stannate
Purified water6.2 Incompatibilities
Iodine, permanganates and other stronger oxidising agents.6.3 Shelf life
Unopened: 2 years
After first opening the container: 28 days6.4 Special precautions for storage
Store below 25ºC, in a dry place.6.5 Nature and contents of container
Crystacide cream is filled into polyethylene tubes pigmented with titanium dioxide, and fitted with polypropylene caps. Each tube is subsequently packed in a unit, printed boxboard carton, in pack sizes of 5g, 10g, 25g and 40g.6.6 Special precautions for disposal and other handling
Not applicable
